🇺🇸 "Metronidazole" and "Lactobacillus" in United States

FDA authorised "Metronidazole" and "Lactobacillus" on 28 August 1981 · 2,110,548 US adverse-event reports

Marketing authorisations

FDA — authorised 28 August 1981

  • Application: ANDA086173
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 22 October 1982

  • Application: NDA018740
  • Marketing authorisation holder: FOSUN PHARMA
  • Status: supplemented

FDA — authorised 17 September 2010

  • Application: ANDA079025
  • Marketing authorisation holder: CHARTWELL RX
  • Status: approved

FDA — authorised 21 December 2011

  • Application: ANDA090653
  • Marketing authorisation holder: HOSPIRA INC
  • Status: approved

FDA — authorised 26 June 2012

  • Application: ANDA090979
  • Marketing authorisation holder: PADAGIS ISRAEL
  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 324,076 reports (15.36%)
  2. Off Label Use — 247,759 reports (11.74%)
  3. Nausea — 242,990 reports (11.51%)
  4. Fatigue — 235,607 reports (11.16%)
  5. Diarrhoea — 195,336 reports (9.26%)
  6. Dyspnoea — 192,220 reports (9.11%)
  7. Headache — 184,411 reports (8.74%)
  8. Pain — 178,677 reports (8.47%)
  9. Dizziness — 157,801 reports (7.48%)
  10. Death — 151,671 reports (7.19%)

Source database →

Frequently asked questions

Is "Metronidazole" and "Lactobacillus" approved in United States?

Yes. FDA authorised it on 28 August 1981; FDA authorised it on 22 October 1982; FDA authorised it on 17 September 2010.

Who is the marketing authorisation holder for "Metronidazole" and "Lactobacillus" in United States?

FOSUN PHARMA holds the US marketing authorisation.